Prevalence and Clinical Spectrum of the 22q11 Deletion
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ClinicalTrials.gov Identifier: NCT00267397 |
Recruitment Status
:
Terminated
(sufficient data collected)
First Posted
: December 21, 2005
Last Update Posted
: May 4, 2007
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Tracking Information | ||||
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First Submitted Date | December 19, 2005 | |||
First Posted Date | December 21, 2005 | |||
Last Update Posted Date | May 4, 2007 | |||
Study Start Date | January 1967 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00267397 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Prevalence and Clinical Spectrum of the 22q11 Deletion | |||
Official Title | Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects | |||
Brief Summary | The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology. | |||
Detailed Description | Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University). A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination. Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices. |
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Study Type | Observational | |||
Study Design | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Congenital Disorders | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Enrollment | Not Provided | |||
Original Enrollment | Not Provided | |||
Study Completion Date | December 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 6 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00267397 | |||
Other Study ID Numbers | 01-107 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | Children's Healthcare of Atlanta | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Children's Healthcare of Atlanta | |||
Verification Date | May 2007 |